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today on philly news feb7 2008 announced virysis trials doing well at controlling viral loads as an alternative option for treatment experienced/ doing trials o 58 hiv possitive anyone know of this still going on and when this will be continueing... anyone here from apple boy if he knows this was a new post this year so trials must be continueing.

For the first time, researchers have slowed and possibly stopped the AIDS virus from reproducing in patients by using a gene therapy that tricks it into self-destructing.

The results, announced Wednesday by Virxsys Corp., are a victory for the biotech start-up in Gaithersburg, Md., and for its collaborators at the University of Pennsylvania.

"The buzzword in the field is viral 'fitness,' meaning how well the virus can replicate," said Gary McGarrity, executive vice president for scientific affairs at Virxsys.

"In eight of the nine patient samples we studied, we see diminished HIV fitness up to two years after treatment."

That raises the hope that even if medical science cannot come up with the Holy Grail of AIDS research - a vaccine to prevent HIV infection - patients may be able to keep HIV under control, perhaps without relying on current drug cocktails, which are both toxic and extremely expensive.

"I think the Virxsys report is very important," said John Rossi, a molecular biologist at the City of Hope in California, who is also working on a gene therapy treatment for HIV.

"A lot of HIV patients are over 60 now and they're suffering the consequences of these toxic drugs. This shows there are alternatives."

The new report is also a sign that gene therapy may finally be a viable approach after 20 years of missteps and controversy - notably the 1999 death of Arizona teenager Jesse Gelsinger in an unrelated Penn gene therapy experiment.

"I think the field is really starting to accelerate," said physician Carl June, who leads the Penn team that is collaborating with Vrxsys. "There was so much frustration for years. But now there are new breakthroughs."

The gene therapy, called VRX496, is still in early human testing intended to demonstrate safety and determine the best dosages. Of the 54 patients who have been treated so far, none have experienced serious side effects, and many have seen clinical signs of effectiveness - their HIV viral loads have fallen and their supply of infection fighting T-cells has grown.

A Penn patient, one of the first and sickest to be treated, remains well more than four years later - even though conventional drugs had stopped working for him.

Yesterday's report, presented by Virxsys at a conference in Boston, looked deep into the molecular level of blood samples from nine randomly chosen patients to see whether the therapy was actually hitting its target.

VRX496 capitalizes on the fact that viruses are impotent on their own - but powerful inside a cell. That is the only place they can replicate, by hijacking the host's molecular machinery. HIV seizes control by splicing its own genes into the DNA of infection-fighting T cells, the backbone of the immune system.

The genetic wizardry involved in outwitting HIV is complex. First, the researchers remove T cells from an HIV patient and insert a gene into the cells that stops the AIDS virus from reproducing. Then, using Penn's patented technology, the T cells are multiplied a hundredfold and put back into the patient.

The vehicle, or "vector," that is used to insert this protective gene into the T cells is novel in itself: a disarmed version of HIV.

The protective gene carries instructions that eliminate the AIDS virus' ability to wrap its DNA in an envelope. So when HIV invades the cell, it steals this envelope-making gene, breaks out - and then finds itself unable to make the armor it needs to invade more cells.

The latest study also found that the protective gene is a double-whammy for HIV. The virus tries to simply delete the gene - its favorite mutating tactic for becoming resistant to conventional drugs - but that, too, reduces its reproductive "fitness." (It gets "wimpy," to use June's word.)

The researchers found that the nine patients' blood samples were loaded with HIV, most of it having mutated into harmless forms.

"For HIV to mutate around our treatment, it has to commit suicide," said McGarrity, the Vrxsys executive.

If the gene therapy becomes an approved treatment, still years away, the estimated cost would be $130,000, said Riku Rautsola, Virxsys' chief executive officer. While that's a hefty sum, the lifetime cost for conventional HIV-fighting drugs is about $700,000.

"We hope [VRX496] will become a frontline therapy once we have proven the impact is durable," Rautsola said. "This would clearly be better in terms of quality of life for the patients."

I think they are refering to the cost of the treatment during a lifetime.Cheaper than ARVs , according to their estimates. Is has got to be this..otherwise, who would be able to afford a downpayment of $130.000??

this is a so beautiful news that I'd like just to add few more details:

Other, similar methods have been investigated for the treatment of HIV, but VIRxSYS says that its approach seems superior to what has come before. "Unlike other viral vectors, lentiviral vectors appear to sustain expression of the delivered genes of interest for a longer period of time," the release said.

Continued the release, "Their safety profiles are currently being evaluated in clinical trials."

Dr. Riku Rautsola, the president and CEO of VIRxSYS, said, "These results are everything we’ve been hoping for."

Added Rautsola, "VRX496 is a remarkably promising treatment for HIV. We are very excited about what we are seeing so far in our trials and are confident that these results will continue into Phase 3."

The VIRxSYS results were presented at CROI on Tuesday, February 5th from 1-4 P

Thanks guys!!! you found it. it truly sounds promising. i guess it will be a few more years of trials.to see how long it works for. unfortunately i live in canada it might take longer i believe it also means this would be more cost effective over ARVs for those resistant and less toxic overall. i cant imagine yet a machine hooked up to every hospital. but it sure would be cool if it was...

Thanks guys!!! you found it. it truly sounds promising. i guess it will be a few more years of trials.to see how long it works for. unfortunately i live in canada it might take longer i believe it also means this would be more cost effective over ARVs for those resistant and less toxic overall. i cant imagine yet a machine hooked up to every hospital. but it sure would be cool if it was...

At this stage of the game, I'm going to lock this thread and ask that you only post messages in the "Am I Infected?" Forum, as this really isn't the place to discuss the uncertainties surrounding your potential exposure to HIV (or HCV) and the next steps you should be taking to get to the bottom of this.

Wonderful, wonderful news. The guy in the article who is doing well 4 years after treatment - wow! That's amazing. Truly innovative therapy. Treatment is probably 5-7 years away yet, but that's ok. If at that point the state of the art treatment for HIV is getting your blood tuned up once every 2 or 3 years and then that's IT - no side-effects, drug interactions, pills everyday etc...... then living with HIV will become a lot simpler and everyone's lifespan and quality of life will improve markedly.

God bless these scientists who come up with this exquisite and life-saving therapy.

Regarding the price, I cannot imagine insurance companies would be allowed to refuse to pay for this. It may only be marginally more expensive than a couple of years of HAART. And if it keeps those with HIV healthy and the claims for ancillary medical conditions down, then there may actually be a financial incentive for insurance companies to pay for this treatment. In any case, I think the cost won't be much of an issue once the treatment has become the standard of care.

This is silly why is thunter person fighting me on posting on new medical breakthroughs, i am simplyly posting new medical breakthroughs. for the sole perpose of shareing knowege e ALL persons Affected and infected in including family and friends, and caregivers to share openly on this site. as stated above. i wish you well. thank you those who wrote to me thanking me on updating new medical news. i admit i am terrible at cut and paste and computers so bare with me. Bless you!

I've been busy getting content onto AIDSmeds in the wake of the recent Retrovirus conference in Boston. I wouldn't have even noticed this thread, started by you, if you hadn't reported yourself to the moderators.

PP, no more posting ANYWHERE on the site, other than in "Am I Infected?" I'm serious -- next time (even in response to this message), it'll be a permanent ban.

What's really pissing me off is your inability to read, not only my warning to you, but also the simple, corteous request -- in the "Research News and Studies" Forum -- that messages drawing attention to a new discovery/research finding include a REFERENCE and LINK to the source of the information. What you're doing here isn't sharing information -- you're spamming the site.

Just out of curiosity: If the gene therapy goes really smoothly, how long will it normally take for a phase II trial goes to phase III and being legally provided in the market? two year? three year? or, another 10 year?

I JUST CAN'T WAIT TO GET RID OF MY MED!! In what kind of condition can FDA expedite the approval?

Since things are moving fairly well, from what I've read, I would speculate that within 2 years we should know whether this will be FDA-approved or not. As far as insurance, I don't see why they wouldn't cover it, considering how expensive it is to currently supply a patients meds and treatment. A one-shot therapy that will keep a patient off meds for a substantial time period, if not permamently, will undoutedly appeal to insurance companies.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

Since things are moving fairly well, from what I've read, I would speculate that within 2 years we should know whether this will be FDA-approved or not. As far as insurance, I don't see why they wouldn't cover it, considering how expensive it is to currently supply a patients meds and treatment. A one-shot therapy that will keep a patient off meds for a substantial time period, if not permamently, will undoutedly appeal to insurance companies.

Two years? Isn't that awfully fast? How long do Phase 3 trials take? If it works, I'd love to see it available ASAP, of course, as would most of us.

I agree that insurance companies, ADAPs, and national health schemes would probably pay for it considering the long-term cost effectiveness. They might gasp a bit first, though (remember the freak-out over the price of T20?).

The genetic wizardry involved in outwitting HIV is complex. First, the researchers remove T cells from an HIV patient and insert a gene into the cells that stops the AIDS virus from reproducing. Then, using Penn's patented technology, the T cells are multiplied a hundredfold and put back into the patient.

The vehicle, or "vector," that is used to insert this protective gene into the T cells is novel in itself: a disarmed version of HIV.

The protective gene carries instructions that eliminate the AIDS virus' ability to wrap its DNA in an envelope. So when HIV invades the cell, it steals this envelope-making gene, breaks out - and then finds itself unable to make the armor it needs to invade more cells.

The latest study also found that the protective gene is a double-whammy for HIV. The virus tries to simply delete the gene - its favorite mutating tactic for becoming resistant to conventional drugs - but that, too, reduces its reproductive "fitness." (It gets "wimpy," to use June's word.)

Sounds a bit like a method that is already being used in Africa! Its a bit of a controversy so I wouldnt want to get some pipo here all cheesed off. So if you want to read about this, google "VANHIVAX". Even more interesting google "VANHIVAX Lipid Sciences". Hope Im not offending anyone.

Well I haven't heard anything from the company itself, but I did hear this from the UPenn test center:

"There are no plans for phase lll trials here at Penn as far as I know. I am still screening and enrolling subjects into our current trial. However, after DSMB recommendations, the protocol is being amended. Participants will require a CD4 > 450, CD4 nadir > 300, and undetectable VL. There will be only 3 infusions in the amended protocol, as opposed to the 6 infused now."

Yes, apparently so, and they'll still recruiting. There's also another site (in New York) that is conducting the trial. They don't seem to know when it will end. At least it is still going on. Let's hope for some speedy results!

Well I haven't heard anything from the company itself, but I did hear this from the UPenn test center:

"There are no plans for phase lll trials here at Penn as far as I know. I am still screening and enrolling subjects into our current trial. However, after DSMB recommendations, the protocol is being amended. Participants will require a CD4 > 450, CD4 nadir > 300, and undetectable VL. There will be only 3 infusions in the amended protocol, as opposed to the 6 infused now."

what does CD4 nadir mean? does that mean never been below that level? Do you think they would accept people from Canada if they could get themselves down there?

Yes, nadir is the lowest CD4 count ever. I think they would consider Canadian participants. I live in Canada, and when I was inquiring about being part of a phase II study, this didn't seem to be an issue. I decided not to do it because it seems rather intensive (frequent monitoring, etc.), so the commute from my home to one of the facilities would have been rather inconvenient (and expensive).

Yes Nadir is the lowest CD4 count you have ever had. This is what kept me from getting into the trial as they changed it right as I was about to enter again. This is indeed some good sounding news! I would think if the trials go without any major hiccups then it should fall under the FDA's accelerated program. As far as the questions I have seen about insurance covering this I honestly don't see why not if it makes a poz person's claims go down. I also would find it hard to believe that an insurance company would decline to cover an FDA approved drug. Now that is not to say they would not. You know how insurance companies are. It could be hard at first then I would say it would become more accessible with time. CheersAppleBoy

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